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ISRCTN
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ISRCTN68552342
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ClinicalTrials.gov identifier
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Public title
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A randomised controlled trial of nasal constant positive airway pressure (NCPAP) as primary therapy for respiratory distress syndrome (RDS) in very pre-term infants.
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Scientific title
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Acronym
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N/A
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Serial number at source
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N0128138699
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Study hypothesis
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Early intubation and surfactant therapy followed by extubation to NCPAP in preterm infants of less than 29 weeks gestation with RDS when compared to continued intubation and intermittent positive pressure ventilation (IPPV) will result in a 50% reduction in chronic lung disease (CLD) (O2 dependency at 36 weeks post menstrual age).
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Neonatal Diseases: Respiratory
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Participants - inclusion criteria
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200 infants
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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07/10/2003
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Anticipated end date
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01/03/2009
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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200 infants
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Interventions
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Early intubation and surfactant therapy followed by extubation to NCPAP compared with continued intubation and intermittent positive pressure ventilation (IPPV)
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Primary outcome measure(s)
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Proportion of infants receiving added oxygen and/or respiratory support at 36 weeks post menstrual age.
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Secondary outcome measure(s)
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1. Days of respiratory support
2. Days of added oxygen
3. Death
4. Pneumothorax rate
5. Sepsis rate (positive blood culture)
6. Trauma rates (nasal septal injury, tracheal stenosis)
7. Change in weight and head circumference centiles between birth and discharge (Z scores).
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Sources of funding
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Liverpool Women's Hospital NHS Trust (UK)
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Trial website
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Publications
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Contact name
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Prof
Richard
Cooke
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Address
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Liverpool Women's Hospital
Crown Street
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City/town
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Liverpool
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Zip/Postcode
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L8 7SS
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Country
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United Kingdom
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Tel
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+44 (0)151 708 9988
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Email
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Sponsor
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Record Provided by the NHSTCT Register - 2004 Update - Department of Health (UK)
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Address
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The Department of Health,
Richmond House,
79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.dh.gov.uk/Home/fs/en
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Date applied
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30/09/2004
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Last edited
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18/04/2008
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Date ISRCTN assigned
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30/09/2004
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